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June 2016 Blog Posts (6)

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

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Added by Adam Fleaming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
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Added by Adam Fleaming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices…
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Added by John Robinson on June 6, 2016 at 2:30am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

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Added by Adam Fleaming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

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Adam Fleaming posted a blog post

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?This is simply not the case. Quality and compliance are built into a medical device…See More
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Adam Fleaming posted a blog post

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither…See More
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OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

OSHA Training, Standards & Best Practices 3 Replies

Get trained on OSHA regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best…Continue

Tags: Webinar, Training, 2011, OSHA, compliance

Started by admin. Last reply by Mymic Mar 15.

FORKLIFT TRAINING CLASSES 21 Replies

Any ideas on how to make Forklift Training Classes more interesting and fun?

Started by Marcia Whatley. Last reply by Mymic Mar 15.

Our Safety in Their Hands 16 Replies

This thought provoking workplace safety infographic features the top 5 organizations that have made the biggest impact on occupational health and safety. It features the U.S governments OSHA,…Continue

Started by Lorenzo Miguel. Last reply by Mymic Mar 15.

OSHA Training on the GHS Labeling System 3 Replies

Anyone wanting to get educated about the new OSHA training requirements on GHS labeling systems should view the free online tutorial at…Continue

Tags: hazcom, 1910.1200, labeling., training, osha

Started by Curtis Chambers, CSP. Last reply by Mymic Mar 15.

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